RecruitingPhase 2NCT05578326

Study of Trilaciclib and Lurbinectidin

Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

30 participants

Start Date

Oct 12, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Lung cancer is by far the leading cause of cancer death among both men and women worldwide and the second most common cancer in terms of new cases. Small cell lung cancer (SCLC) is the deadliest form of lung cancer. The standard first-line treatment is the combination of carboplatin, etoposide, and atezolizumab. While response rates for this regimen are high (roughly 60%), the duration of response is short, typically 4 months. Following progression after the 1st line treatment of SCLC, there is no consensus regarding subsequent therapy. Lurbinectedin is FDA approved and is increasingly preferred in clinical practice. Toxicity was significant, but appeared favorable compared to historic results with topotecan, leading to the adoption of this therapy for second-line SCLC. The toxicity profile was dominated by myelosuppression. This study investigates the effect of Trilaciclib on myelosuppression rate in subjects with platinum refractory extensive stage (ES)- SCLC receiving Lurbinectedin as well as the clinical synergy of Trilaciclib and Lurbinectedin combination.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — trilaciclib and lurbinectedin — in people with advanced cancer. Trilaciclib helps protect bone marrow during chemotherapy, while lurbinectedin is a chemotherapy drug. Researchers want to see how safe and effective this combination is. **You may be eligible if...** - You are 18 or older - You have advanced cancer that can be measured on scans - You have previously been treated with a platinum-based chemotherapy drug, and a PD-1 or PD-L1 immunotherapy drug - You are in good physical condition (able to carry out normal daily activities with minimal effort) **You may NOT be eligible if...** - You have an active infection requiring treatment with antibiotics or antivirals - You are pregnant or breastfeeding - You have received another experimental treatment within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrilaciclib

240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle

DRUGLurbinectedin

3.2 mg/m2, over 60 minutes at day 1 of each cycle


Locations(2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT05578326


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